Applies to the following strength(s): 60 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Dyspareunia
60 mg orally once a day with food
Duration of therapy: Shortest period of time, consistent with treatment goals and risks for the individual woman
-When a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer.
-Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Use: Treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy, due to menopause
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Mild to moderate liver dysfunction (Child-Pugh Class A and B) : No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Not recommended.
US BOXED WARNINGS:
-ENDOMETRIAL CANCER: This drug is an estrogen agonist/antagonist with tissue selective effects, and it has estrogen agonistic effects in the endometrium. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
-CARDIOVASCULAR DISORDERS: There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily 0.625 mg of oral estrogen-alone therapy over 7.1 years as part of the Women's Health Initiative (WHI).
In the clinical trials (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 0.72 and 1.45 per thousand women, respectively in Ospemifene 60 mg treatment group and 1.04 and 0 in placebo. The incidence of DVT was 1.45 per thousand women in Ospemifene 60 mg treatment group and 1.04 per thousand women in placebo. This drug should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug should be taken with food.
Monitoring: Reevaluate the patient periodically as clinically appropriate to determine if treatment is still necessary.
-Patients should report unusual vaginal bleeding as soon as possible.
-This drug may initiate or increase the occurrence of hot flashes in some women.
More about ospemifene
- Other brands: Osphena